St. Jude warns of heart-device battery issue linked to 2 deaths

By Jim Finkle

Oct 11 St. Jude Medical Inc warned on
Tuesday that some of its implanted heart devices are at risk of
premature battery depletion, a condition it said has been linked
to two patient deaths and could require the replacement of some
devices.

News of the issue surfaced on Monday evening when
short-selling firm Muddy Waters tweeted a copy of a physician
advisory on the matter from St. Jude, which agreed in April to
sell itself for $25 billion to Abbott Laboratories.

That letter said such problems with the lithium batteries
that power the devices were rare and could be identified by
patients using tools for monitoring battery levels from their
homes.

Out of nearly 400,000 devices manufactured through May of
last year, the company has identified 841 failed implanted
cardioverter defibrillators with lithium clusters, which can
form after a device delivers electricity to the heart, according
to St. Jude.

Lithium clusters sometimes cause battery power to deplete
quickly, making devices unable to deliver doses of electricity
when needed, St. Jude Vice President of Quality Control Jeff
Fecho said in the letter to physicians.

"There have been two deaths that have been associated with
the loss of defibrillation therapy as a result of premature
battery depletion," Fecho said.

The company advised physicians to replace devices with
damaged batteries immediately, but cautioned against swapping
out devices that were operating normally because of the
potential for complications from such procedures.

"We encourage any patient with questions about their medical
device to contact their doctor," St. Jude Chief Medical Officer
Mark Carlson said in a statement.

"While this risk is very small, we have provided doctors
with information so that they can discuss the most appropriate
course of action for each individual patient," Carlson said.

St. Jude said it planned to launch a webpage on Tuesday
where patients could see which devices were affected: (www.sjm.com/batteryadvisory).

The site tells patients how they can monitor battery
activity, look for vibrating alerts when batteries are low and
connect to the Merlin.net remote monitoring service.

The alert comes as St. Jude defends itself against unrelated
allegations that its heart devices are riddled with bugs that
make them vulnerable to fatal cyber hacks.

The Food and Drug Administration is investigating the claims
by Muddy Waters and research firm MedSec Holdings Inc.

St. Jude has denied the allegations and sued both firms,
saying they disseminated false information to manipulate its
stock price.